Plaque PsoriasisPhase 3NCT02701205
Safety and Efficacy Study of Etanercept (Qiangke®) to Treat Moderate to Severe Plaque Psoriasis
A Phase 3 study testing etanercept and etanercept (half dose) in people with Plaque Psoriasis and Psoriasis, run by Shanghai Celgen Bio-Pharmaceutical Co.,Ltd at 4 sites in China.
Trial summary
This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy and safety of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection (Qiangke®) in the treatment of Moderate to Severe Plaque Psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plaque Psoriasis, Psoriasis
- What is being tested?
- etanercept and etanercept (half dose)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 4 sitesChina
- Study dates
- Jan 2015to Dec 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female, age 18-65,Asian.
- Freely provides both verbal and written informed consent.
- Consent to use effective contraception during the trial period.
- Participant had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis
- Participant must have a Psoriasis Area Severity Index score greater than or equal to 12 at the baseline visit and Body Surface Area involvement greater than or equal to 10% at the baseline visit.
- Participant has previous exposure to systemic psoriasis therapy or phototherapy, but not ideal.
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- Meet the following criteria for Tuberculosis screening: A. has no prior history of occult or active tuberculosis. B. No signs or symptoms of active tuberculosis in history and / or physical examination. C. in the first 6 weeks of the trial, tuberculosis screening test meet the requirements of the trial.
- Laboratory screening results:Hemoglobin≥110g/L.White blood cell≥4 * 109 /L. Neutrophil≥1.5 * 109/L.Platelet≥100 * 109/L.Serum alanine aminotransferase and / or aspartate aminotransferase not more than 1.5 times of the upper limit of normal.Serum creatinine does not exceed 1.5 mg/dL (International units: ≤133 mol/L).
- During the first 2 weeks of the study, Participant must stop adjuvant therapy including traditional Chinese medicine and acupuncture.
- Hepatitis B (HBV) screening in compliance with the requirements of this test.
- Weight≥60Kg.
Who cannot join
- Pustular, erythrodermic, and/or guttate forms of psoriasis.
- Participant had treated with TNF antagonists within 6 weeks prior to the Baseline visit.
- Participant had treated with Other biological agents within 6 weeks prior to the Baseline visit.
- Participant had treated with Phototherapy or systemic antipsoriatic treatment (such as:Methotrexate（MTX）， acitretin, cyclosporine, Total Glucosides of Paeony（TGP）, treatment of psoriasis related Chinese medicines, etc.) and systemic corticosteroid treatment within 4 weeks prior to the Baseline visit.
- Participant had treated with Topical corticosteroid therapy, vitamin A or D analogue or Anthralin within 2 weeks prior to the Baseline visit.
- Participant received any drug that the drug's metabolism was less than 7 half lives before the Baseline visit.
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- Participant plans to pregnant or breast feeding or father during the study.
- The history of occult or active granuloma infections, including histoplasmosis, coccidioidomycosis.
- Participant has suffered from Non Mycobacterium tuberculosis infection or opportunistic infections (such as cytomegalovirus sense of dyeing, Pneumocystis carinii pneumonia, aspergillosis) within 6 weeks prior to the Baseline visit.
- The close contact history of active tuberculosis patients or Tuberculosis screening results do not meet the requirements.
- Participant has suffered from severe infection (for example hepatitis, pneumonia, acute pyelonephritis or sepsis), or participant use intravenous antibiotics now because of infection within 6 weeks prior to the Baseline visit.
- Participant has suffered from chronic or recurrent infections before or at present, including (but not limited to) chronic kidney infection disease and chronic chest infectious diseases (such as bronchial dilation), sinusitis, recurrent urinary tract infections (such as recurrent pyelonephritis and chronic non remission cystitis), open, overflow liquid or infection of skin wound or ulcer.
- Human immunodeficiency virus (HIV) antibody positive.
- Hepatitis B virus (HBV) screening results do not meet the requirements.
- Hepatitis C virus (HCV) antibody positive.
- Participant has demyelinating diseases such as multiple sclerosis or optic neuritis.
- A history of congestive heart failure, including asymptomatic congestive heart failure.
- A history or sign of a lymph node hyperplasia, including lymphoma or suggestive of a possible sign such as the size and location of an enlarged lymph node or a history of clinically significant enlargement of the spleen.
- Participant has symptoms or signs of severe, progressive or uncontrolled kidney, liver, blood, gastrointestinal, endocrine, lung, heart, nerve, mental or brain diseases.
- There is a history of malignancy or previous history.
- Joint prosthesis has not yet been removed or replaced.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, 100730
Hongzhong Jin, M.D.
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Qing Sun, M.D.
- Recruiting
Institute of Dermatology and Skin Disease Hospital Chinese Academy of Medical Sciences
Nanjing, Jiangsu, 210042
Heng Gu, M.D.
- Recruiting
Changhai Hospital of The Second Military Medical University
Shanghai, Shanghai Municipality, 200433
Jun Gu, M.D.
About this study
Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Safety and Efficacy Study of Recombinant Human TNF Receptor-IgG Fusion Protein for Injection (Qiangke®) to Treat Moderate to Severe Plaque Psoriasis
This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy and safety of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection (Qiangke®) in the treatment of Moderate to Severe Plaque Psoriasis. The primary purpose is to assess the different maintaining treatment programme in Moderate to Severe plaque psoriasis by Qiangke®. And the second purpose is to assess the efficacy and safety of Qiangke® in Moderate to Severe Plaque Psoriasis. The trial will include 216 Moderate to Severe plaque psoriasis patients,and at the first stage they will be randomized divided into three group: full-dose of Qiangke® group, half-dose of Qiangke® group and placebo group.And the blind stage will last for 12 weeks. Then at the second stage, all patients will receive 50mg qw of Qiangke® for additional 12 weeks.
Read the detailed description
Psoriasis is a chronic inflammatory skin disease that can lead to significant physical and psychologic distress for patients.Recombinant Human TNF Receptor-Ig Fusion Protein for Injection (Qiangke®) can block the role of the cytokine tumor necrosis factor (TNF)-alpha.
TNF-α plays a major role in the pathophysiology of both Psoriasis（PsO）and Psoriatic Arthritis (PsA). TNF-α levels are elevated in psoriatic skin lesions, serum samples, and synovial fluid. Anti-TNF-α therapy has shown efficacy in treating psoriatic skin lesions, joint pain and swelling, enthesitis, and dactylitis plus the ability to improve mobility, reduce radiographic progression of disease, and influence quality of life parameters.
Qiangke® is a dimeric, soluble fusion protein consisting of the extracellular ligand binding portion of the TNF receptor linked to the Fc portion of human Immunoglobulin gamma-1（IgG1）. It is capable of binding and neutralizing soluble TNF and transmembrane TNF. It alters neutrophil migration and dendritic cell and T-cell maturation and migration, thus decreasing the local and systemic production of pro-inflammatory cytokines and their subsequent effects.
- Conditions
- Plaque Psoriasis, Psoriasis
- Being tested
- etanercept, etanercept (half dose), placebo
- Keywords
- Plaque Psoriasis, Skin Disease
- Medical subject headings
- Psoriasis, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etanerceptBiological
Also called Qiangke®
Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50mg twice a week by subcutaneous injection for 12 weeks, At the end of the first 12 weeks, all subjects will be treated with Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50 mg once a week for an additional 12 weeks.
etanercept (half dose)Biological
Also called Qiangke®
Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 25mg twice a week by subcutaneous injection for 12 weeks, At the end of the first 12 weeks, all subjects will be treated with Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50 mg once a week for an additional 12 weeks.
placeboDrug
two vials of placebo twice a week by subcutaneous injection for 12 weeks, At the end of the first 12 weeks, all subjects will be treated with Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50 mg once a week for an additional 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| etanercept | Experimental | Recombinant Human TNF Receptor-Ig Fusion Protein for Injection（Qiangke®) 50mg twice a week for 12 weeks, then Two vials of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 25mg twice a week from Week 12 to Week 24 Receives: Biological: etanercept |
| etanercept (half dose) | Experimental | One vial of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection（Qiangke®） 25mg and one vial of placebo twice a week for 12 weeks, then Two vials of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 25mg twice a week from Week 12 to Week 24 Receives: Biological: etanercept (half dose) |
| Placebo | Placebo comparator | Two vials of Placebo twice a week for 12 weeks, then Two vials of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection（Qiangke®) 25mg twice a week from Week 12 to Week 24 Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at Week 12
Measured: Week 12
Secondary outcomes (6)
Proportion of subjects achieving PASI 90 & 50
Measured: Week 12
Proportion of subjects achieving PASI 90 & 50 & 75
Measured: Week 24
Physician's Global Assessment (PGA)
Measured: Week 12 & 24
Nail Psoriasis Severity Index (NAPSI)
Measured: Week 12 & 24
Dermatology Life Quality Index (DLQI)
Measured: Week 12 & 24
Patient's Global Assessment (PGA)
Measured: Week 12 & 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Celgen Bio-Pharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongzhong Jin, M.D., Principal investigator, Chinese Academy of Medical Sciences Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701205
- Sponsor's protocol ID
- QRSTPP
- Status last verified
- Mar 2016
- First submitted
- 28 Feb 2016
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Gottlieb AB, Chamian F, Masud S, Cardinale I, Abello MV, Lowes MA, Chen F, Magliocco M, Krueger JG. TNF inhibition rapidly down-regulates multiple proinflammatory pathways in psoriasis plaques. J Immunol. 2005 Aug 15;175(4):2721-9. doi: 10.4049/jimmunol.175.4.2721.
PubMed 16081850Gudjonsson JE, Elder JT. Psoriasis: epidemiology. Clin Dermatol. 2007 Nov-Dec;25(6):535-46. doi: 10.1016/j.clindermatol.2007.08.007.
PubMed 18021890Gupta MA, Gupta AK. Depression and suicidal ideation in dermatology patients with acne, alopecia areata, atopic dermatitis and psoriasis. Br J Dermatol. 1998 Nov;139(5):846-50. doi: 10.1046/j.1365-2133.1998.02511.x.
PubMed 9892952Leonardi CL, Powers JL, Matheson RT, Goffe BS, Zitnik R, Wang A, Gottlieb AB; Etanercept Psoriasis Study Group. Etanercept as monotherapy in patients with psoriasis. N Engl J Med. 2003 Nov 20;349(21):2014-22. doi: 10.1056/NEJMoa030409.
PubMed 14627786Kivelevitch D, Mansouri B, Menter A. Long term efficacy and safety of etanercept in the treatment of psoriasis and psoriatic arthritis. Biologics. 2014 Apr 17;8:169-82. doi: 10.2147/BTT.S41481. eCollection 2014.
PubMed 24790410Papp KA, Tyring S, Lahfa M, Prinz J, Griffiths CE, Nakanishi AM, Zitnik R, van de Kerkhof PC, Melvin L; Etanercept Psoriasis Study Group. A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction. Br J Dermatol. 2005 Jun;152(6):1304-12. doi: 10.1111/j.1365-2133.2005.06688.x.
PubMed 15948997Sterry W, Ortonne JP, Kirkham B, Brocq O, Robertson D, Pedersen RD, Estojak J, Molta CT, Freundlich B. Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTA randomised double blind multicentre trial. BMJ. 2010 Feb 2;340:c147. doi: 10.1136/bmj.c147.
PubMed 20124563Chiu HY, Wang TS, Cho YT, Tsai TF. Etanercept use for psoriasis in Taiwan: a case series study. Int J Dermatol. 2013 Jun;52(6):673-80. doi: 10.1111/j.1365-4632.2011.05273.x. Epub 2012 Feb 20.
PubMed 22348620
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Safety and Efficacy Study of Recombinant Human TNF Receptor-IgG Fusion Protein for Injection (Qiangke®) to Treat Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT02701205
- Acronym / sponsor ID
- QRSTPP
- Conditions
- Plaque Psoriasis, Psoriasis
- Keywords
- Plaque Psoriasis, Skin Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Shanghai Celgen Bio-Pharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy and safety of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection (Qiangke®) in the treatment of Moderate to Severe Plaque Psoriasis. The primary purpose is to assess the different maintaining treatment programme in Moderate to Severe plaque psoriasis by Qiangke®. And the second purpose is to assess the efficacy and safety of Qiangke® in Moderate to Severe Plaque Psoriasis. The trial will include 216 Moderate to Severe plaque psoriasis patients,and at the first stage they will be randomized divided into three group: full-dose of Qiangke® group, half-dose of Qiangke® group and placebo group.And the blind stage will last for 12 weeks. Then at the second stage, all patients will receive 50mg qw of Qiangke® for additional 12 weeks.
Detailed description
Psoriasis is a chronic inflammatory skin disease that can lead to significant physical and psychologic distress for patients.Recombinant Human TNF Receptor-Ig Fusion Protein for Injection (Qiangke®) can block the role of the cytokine tumor necrosis factor (TNF)-alpha.
TNF-α plays a major role in the pathophysiology of both Psoriasis（PsO）and Psoriatic Arthritis (PsA). TNF-α levels are elevated in psoriatic skin lesions, serum samples, and synovial fluid. Anti-TNF-α therapy has shown efficacy in treating psoriatic skin lesions, joint pain and swelling, enthesitis, and dactylitis plus the ability to improve mobility, reduce radiographic progression of disease, and influence quality of life parameters.
Qiangke® is a dimeric, soluble fusion protein consisting of the extracellular ligand binding portion of the TNF receptor linked to the Fc portion of human Immunoglobulin gamma-1（IgG1）. It is capable of binding and neutralizing soluble TNF and transmembrane TNF. It alters neutrophil migration and dendritic cell and T-cell maturation and migration, thus decreasing the local and systemic production of pro-inflammatory cytokines and their subsequent effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| etanercept | Experimental | Biological: etanerceptRecombinant Human TNF Receptor-Ig Fusion Protein for Injection（Qiangke®) 50mg twice a week for 12 weeks, then Two vials of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 25mg twice a week from Week 12 to Week 24 |
| etanercept (half dose) | Experimental | Biological: etanercept (half dose)One vial of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection（Qiangke®） 25mg and one vial of placebo twice a week for 12 weeks, then Two vials of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 25mg twice a week from Week 12 to Week 24 |
| Placebo | Placebo comparator | Drug: placeboTwo vials of Placebo twice a week for 12 weeks, then Two vials of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection（Qiangke®) 25mg twice a week from Week 12 to Week 24 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or Female, age 18-65,Asian.
- Freely provides both verbal and written informed consent.
- Consent to use effective contraception during the trial period.
- Participant had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis
- Participant must have a Psoriasis Area Severity Index score greater than or equal to 12 at the baseline visit and Body Surface Area involvement greater than or equal to 10% at the baseline visit.
Key exclusion criteria (21 listed)
- Pustular, erythrodermic, and/or guttate forms of psoriasis.
- Participant had treated with TNF antagonists within 6 weeks prior to the Baseline visit.
- Participant had treated with Other biological agents within 6 weeks prior to the Baseline visit.
- Participant had treated with Phototherapy or systemic antipsoriatic treatment (such as:Methotrexate（MTX）， acitretin, cyclosporine, Total Glucosides of Paeony（TGP）, treatment of psoriasis related Chinese medicines, etc.) and systemic corticosteroid treatment within 4 weeks prior to the Baseline visit.
- Participant had treated with Topical corticosteroid therapy, vitamin A or D analogue or Anthralin within 2 weeks prior to the Baseline visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| etanerceptAlso: Qiangke®Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50mg twice a week by subcutaneous injection for 12 weeks, At the end of the first 12 weeks, all subjects will be treated with Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50 mg once a week for an additional 12 weeks. | Biological | etanercept |
| etanercept (half dose)Also: Qiangke®Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 25mg twice a week by subcutaneous injection for 12 weeks, At the end of the first 12 weeks, all subjects will be treated with Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50 mg once a week for an additional 12 weeks. | Biological | etanercept (half dose) |
| placebotwo vials of placebo twice a week by subcutaneous injection for 12 weeks, At the end of the first 12 weeks, all subjects will be treated with Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50 mg once a week for an additional 12 weeks. | Drug | Placebo |
Primary outcome
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at Week 12
Time frame: Week 12
6 secondary outcomes
Proportion of subjects achieving PASI 90 & 50
Time frame: Week 12
Proportion of subjects achieving PASI 90 & 50 & 75
Time frame: Week 24
Physician's Global Assessment (PGA)
Time frame: Week 12 & 24
Nail Psoriasis Severity Index (NAPSI)
Time frame: Week 12 & 24
Dermatology Life Quality Index (DLQI)
Time frame: Week 12 & 24
Patient's Global Assessment (PGA)
Time frame: Week 12 & 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- Background: PubMed 16081850Gottlieb AB, Chamian F, Masud S, Cardinale I, Abello MV, Lowes MA, Chen F, Magliocco M, Krueger JG. TNF inhibition rapidly down-regulates multiple proinflammatory pathways in psoriasis plaques. J Immunol. 2005 Aug 15;175(4):2721-9. doi: 10.4049/jimmunol.175.4.2721.
- Background: PubMed 18021890Gudjonsson JE, Elder JT. Psoriasis: epidemiology. Clin Dermatol. 2007 Nov-Dec;25(6):535-46. doi: 10.1016/j.clindermatol.2007.08.007.
- Background: PubMed 9892952Gupta MA, Gupta AK. Depression and suicidal ideation in dermatology patients with acne, alopecia areata, atopic dermatitis and psoriasis. Br J Dermatol. 1998 Nov;139(5):846-50. doi: 10.1046/j.1365-2133.1998.02511.x.
- Results publication: PubMed 14627786Leonardi CL, Powers JL, Matheson RT, Goffe BS, Zitnik R, Wang A, Gottlieb AB; Etanercept Psoriasis Study Group. Etanercept as monotherapy in patients with psoriasis. N Engl J Med. 2003 Nov 20;349(21):2014-22. doi: 10.1056/NEJMoa030409.
- Results publication: PubMed 24790410Kivelevitch D, Mansouri B, Menter A. Long term efficacy and safety of etanercept in the treatment of psoriasis and psoriatic arthritis. Biologics. 2014 Apr 17;8:169-82. doi: 10.2147/BTT.S41481. eCollection 2014.
- Results publication: PubMed 15948997Papp KA, Tyring S, Lahfa M, Prinz J, Griffiths CE, Nakanishi AM, Zitnik R, van de Kerkhof PC, Melvin L; Etanercept Psoriasis Study Group. A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction. Br J Dermatol. 2005 Jun;152(6):1304-12. doi: 10.1111/j.1365-2133.2005.06688.x.
- Results publication: PubMed 20124563Sterry W, Ortonne JP, Kirkham B, Brocq O, Robertson D, Pedersen RD, Estojak J, Molta CT, Freundlich B. Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTA randomised double blind multicentre trial. BMJ. 2010 Feb 2;340:c147. doi: 10.1136/bmj.c147.
- Results publication: PubMed 22348620Chiu HY, Wang TS, Cho YT, Tsai TF. Etanercept use for psoriasis in Taiwan: a case series study. Int J Dermatol. 2013 Jun;52(6):673-80. doi: 10.1111/j.1365-4632.2011.05273.x. Epub 2012 Feb 20.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongzhong Jin, M.D. principal investigator
Chinese Academy of Medical Sciences Peking Union Medical College
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing etanercept and etanercept (half dose) in people with Plaque Psoriasis and Psoriasis, run by Shanghai Celgen Bio-Pharmaceutical Co.,Ltd at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongzhong Jin, M.D. (8613693583080, jinhongzhong@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02701205, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.